NCT02049970

Brief Summary

the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

January 28, 2014

Last Update Submit

November 7, 2014

Conditions

Sequelae of Fracture of Forearm and Upper Arm

Keywords

Supraclavicular block

Outcome Measures

Primary Outcomes (1)

  • the duration of sensorial block

    pin-prick test

    postoperative 1 day

Secondary Outcomes (1)

  • the first time analgesic required

    postoperative 1 day

Study Arms (2)

dexmedetomidine and bupivacaine

EXPERIMENTAL

Bupivacaine 50 mg and dexmedetomidine 1 microgram/kg

Drug: dexmedetomidineDrug: bupivacaine

Bupivacaine and placebo

EXPERIMENTAL

Bupivacaine 100 mg and SF 10 ml

Drug: dexmedetomidineDrug: bupivacaine

Interventions

dexmedetomidineDRUG

1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus

Also known as: precedex
Bupivacaine and placebodexmedetomidine and bupivacaine
bupivacaineDRUG

30 ml 0.25 % bupivacaine is applied around brachial plexus

Also known as: marcaine
Bupivacaine and placebodexmedetomidine and bupivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • unwanted general anaesthesia
  • ASA 1-2
  • single forearm, arm surgery

You may not qualify if:

  • major psychiatric problems
  • major neurologic deficits
  • coagulopathy
  • drug allergies
  • chronic analgesic used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medical Faculty

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Interventions

DexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Recep Aksu

    Ass.Prof.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

TU(1)